Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Premarket Assessment of Pediatric Medical Devices.” This guidance presents FDA's current thinking on the type of safety and effectiveness information needed to support marketing of pediatric devices and on measures to be used to help protect this vulnerable patient population during the course of clinical trials involving such products.
Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time.
Submit written requests for single copies on a 3.5″ diskette of the guidance document entitled “Premarket Assessment of Pediatric Medical Devices” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ–220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive labels to assist that office in processing your request, or fax your request to 301–443–8818. See the
Submit written comments concerning this guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
On October 26, 2002, the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), Public Law 107–250, was signed into law. Among other things, MDUFMA amends the Federal Food, Drug, and Cosmetic Act (the act) by adding several new provisions concerning devices intended for pediatric use. MDUFMA requires FDA, within 270 days of enactment, to issue guidance on the safety and effectiveness information needed to support marketing of pediatric devices and on measures to be used to help protect this vulnerable patient population during the course of clinical trials involving such products.
On February 4, 2003, FDA published a
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on premarket assessment of pediatric medical devices. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
To receive “Premarket Assessment of Pediatric Medical Devices” by fax, call the Center for Devices and Radiological Health (CDRH) Facts-On-Demand system at 800–899–0381 or 301–827–0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (1220) followed by the pound sign (#). Follow the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the guidance may also do so by using the Internet. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. The CDRH web site may be accessed at
This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520) (the PRA). The collections of information addressed in the guidance document have been approved by OMB in accordance with the PRA under the regulations governing premarket notification submissions (21 CFR part 807, subpart E, OMB control number 0910–0120) and premarket approval applications (21 CFR part 814, OMB control number 0910–0231). The labeling provisions addressed in the guidance have been approved by OMB under OMB control number 0910–0485.
Interested persons may submit to the Division of Dockets Management (see